Memantine and Postoperative Pain
Memantine for Postoperative Analgesia
1 other identifier
interventional
77
1 country
1
Brief Summary
Memantine is associated with improvement in pain relief after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Dec 2009
Longer than P75 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
March 14, 2016
CompletedMarch 14, 2016
January 1, 2016
5.1 years
December 14, 2009
January 19, 2016
February 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
24 hr Opioid Consumption
24 hr
Secondary Outcomes (6)
Pain Scores
48 hours
Opioid Related Side Effects
0-24 h
Opioid Related Side Effects: Pruritus
0-24 h
Hyperalgesia
Within 48 h
Patient Satisfaction
48 hours
- +1 more secondary outcomes
Study Arms (2)
Memantine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male
- Age 18 to 75 years old
You may not qualify if:
- Chronic pain conditions or taking regular analgesics
- Taking psychotropic medications
- Parkinson's disease
- Narrow-angle glaucoma
- Known gastroduodenal ulcer
- History of seizure disorder
- Renal insufficiency, as defined by serum creatinine greater than 2 mg/dL
- Liver disease, including liver failure, cirrhosis, or acute hepatitis
- Significant coronary vascular disease or cardiac conduction system disease, as noted by ECG or history of cardiac symptoms, or cardiac ejection fraction less than 30%
- American Society of Anesthesiologists (ASA) score of 4 or higher
- Allergy to ketorolac or memantine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ashraf Habib
- Organization
- Duke University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 15, 2009
Study Start
December 1, 2009
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 14, 2016
Results First Posted
March 14, 2016
Record last verified: 2016-01